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Interactive Intention-Driven Upper-Limb Training Robotic System

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Hand Robotic Training
Hand and Arm Robotic Training
Conventional therapy
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Hand, Upper Extremity, Robotics

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.

Exclusion Criteria:

  • Excessive spasticity of the affected arm
  • Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Hand Robotic Training

Hand and Arm Robotic Training

Conventional therapy

Arm Description

Hand Robotic Training

Hand and Arm Robotic Training

Conventional therapy

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment
Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months. Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Action Research Arm Test
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.

Secondary Outcome Measures

Wolf Motor Function Test
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
modified Ashworth Scale
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.

Full Information

First Posted
February 27, 2014
Last Updated
February 23, 2017
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02077439
Brief Title
Interactive Intention-Driven Upper-Limb Training Robotic System
Official Title
Trial: Interactive Intention-Driven Upper-Limb Training Robotic System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.
Detailed Description
This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system. Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour. During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy. There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Hand, Upper Extremity, Robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hand Robotic Training
Arm Type
Experimental
Arm Description
Hand Robotic Training
Arm Title
Hand and Arm Robotic Training
Arm Type
Experimental
Arm Description
Hand and Arm Robotic Training
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
Conventional therapy
Intervention Type
Device
Intervention Name(s)
Hand Robotic Training
Intervention Description
Training for 20 sessions for one hour, 3-5 times per week.
Intervention Type
Device
Intervention Name(s)
Hand and Arm Robotic Training
Intervention Description
Training for 20 sessions for one hour, 3-5 times per week.
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
Training for 20 sessions for one hour, 3-5 times per week.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months. Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Time Frame
Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
Title
Action Research Arm Test
Description
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Time Frame
Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Time Frame
Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months
Title
modified Ashworth Scale
Description
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Time Frame
Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour. Exclusion Criteria: Excessive spasticity of the affected arm Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond KY Tong, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Links:
URL
http://www.polyu.edu.hk
Description
The Hong Kong Polytechnic University

Learn more about this trial

Interactive Intention-Driven Upper-Limb Training Robotic System

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